Recruiting

Medically Tailored Meals

Sponsor:

Washington University School of Medicine

Code:

NCT07924241

Conditions

Cancer

Healthy Eating

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Medically Tailored Meals

Nutrition Education

Study Details

Brief summary:

The purpose of this study is to assess the feasibility, acceptability, preliminary outcomes, and participant and implementation partners experiences with a community-engaged Medically Tailored Meals (MTM) stepdown pilot intervention designed to support sustained healthy eating behaviors and cancer-related outcomes among food-insecure adults with cancer in the St. Louis region.

Conditions

Cancer

Healthy Eating

Study ID

NCT07924241

Start date

Nov 30, 2026

Status verified date

Nov, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria for Stepdown Intervention Participants:

  • Enrolled in and graduating from the Food Outreach MTM Cancer program; defined as having completed 12-months of services from intake date and no longer undergoing active cancer treatment as confirmed through a routine recertification assessment conducted by a Food Outreach dietitian

Exclusion Criteria for Stepdown Intervention Participants:

  • Never enrolled in the Food Outreach MTM Cancer program OR actively enrolled in the Food Outreach MTM Cancer program and not meeting criteria for graduation, defined as having been enrolled for less than 12 months from intake date and/or still undergoing active cancer treatment

Inclusion Criteria for Qualitative Interviews with Stepdown Intervention Participants:

  • Participated in the Food Outreach MTM pilot stepdown program

Exclusion Criteria for Qualitative Interviews with Stepdown Intervention Participants:

  • Did not complete the Food Outreach MTM stepdown pilot intervention

Inclusion Criteria for Key Informants:

  • Past, current, or prospective involvement in the referral, delivery, funding, or organizational partnership of Food Outreach's MTM Cancer Program.

Exclusion Criteria for Key Informants:

  • No past, current, or prospective involvement in the referral, delivery, funding, or organizational partnership of Food Outreach's MTM Cancer Program.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Medically Tailored Meals (MTM) Stepdown Intervention

Participants will be provided with monthly food boxes and tailored nutrition education over three months following graduation from the Food Outreach MTM Cancer Program.

Participants will be contacted by program staff, at the point of graduation of a 12-month MTM Cancer program prior to starting the stepdown intervention, and again following completion of the 3-month stepdown intervention. Contact will be made via phone, in person, or by electronic communication.

Following completion of the stepdown intervention, participants will be invited to complete an optional semi-structured qualitative interview. Participant data from their enrollment into the original 12 month program will also be shared with the research team.

no intervention: Key Informants

Key informant interviews will be conducted on a rolling basis n=12-15 organization leaders, n=12-15 referral partners). All interviews are expected to take no more than 60 minutes and will be conducted by a trained study team member using a semi-structured interview guide. Key informants will be asked how they perceive the implementation, effectiveness, and sustainability of the MTM program and stepdown intervention.

Interventions

Medically Tailored Meals

Participants will receive medically tailored meals monthly through Food Outreach for three months after graduation from the MTM Cancer Program. MTM are designed by a registered dietitian and include frozen medically tailored meals, medically tailored groceries and fresh produce tailored for each participant.

Nutrition Education

Nutrition education will be provided by a registered dietitian and designed to support the transition to independent healthy eating during cancer survivorship. Nutrition education materials were developed by Food Outreach.

Primary outcome measure

  • Enrollment Number [ Time Frame: Start through completion of recruitment period (estimated to be 3-4 months) ]
  • Number of successful deliveries per participant of monthly food boxes and nutrition education components education components [ Time Frame: From start to completion of the stepdown intervention (total time 3 months) ]
  • Number of Participants Completing Stepdown Intervention [ Time Frame: At completion of stepdown intervention (total time 3 months) ]
  • Participant satisfaction as assessed by Net Promoter Score (NPS) [ Time Frame: At completion of the 12-month MTM program (enrollment in stepdown intervention - Visit 2) and 2-4 weeks after conclusion of stepdown intervention (Visit 3) (total time 3.5-4 months after enrollment) ]
  • Participant experience as assessed by the MTM Program Experience and Satisfaction survey [ Time Frame: At completion of the 12-month MTM program (enrollment in stepdown intervention - Visit 2) and 2-4 weeks after conclusion of stepdown intervention (Visit 3) (total time 3.5-4 months after enrollment) ]
  • Changes in food insecurity as measured by the Food Security Survey [ Time Frame: At completion of the 12-month MTM program (enrollment in stepdown intervention - Visit 2) and 2-4 weeks after conclusion of stepdown intervention (Visit 3) (total time 3.5-4 months after enrollment) ]
  • Changes in nutrition security as measured by the four-item nutrition security screener [ Time Frame: At completion of the 12-month MTM program (enrollment in stepdown intervention - Visit 2) and 2-4 weeks after conclusion of stepdown intervention (Visit 3) (total time 3.5-4 months after enrollment) ]
  • Changes in nutrition quality as assessed through Diet Quality Recall Survey [ Time Frame: At completion of the 12-month MTM program (enrollment in stepdown intervention - Visit 2) and 2-4 weeks after conclusion of stepdown intervention (Visit 3) (total time 3.5-4 months after enrollment) ]
  • Changes in dietary consumption as assessed through Food Outreach Cancer Client Nutrition Assessment Form [ Time Frame: At completion of the 12-month MTM program (enrollment in stepdown intervention - Visit 2) and 2-4 weeks after conclusion of stepdown intervention (Visit 3) (total time 3.5-4 months after enrollment) ]
  • Changes in participant self-efficacy score [ Time Frame: At completion of the 12-month MTM program (enrollment in stepdown intervention - Visit 2) and 2-4 weeks after conclusion of stepdown intervention (Visit 3) (total time 3.5-4 months after enrollment) ]

Central Contacts and Locations

Central contacts

Daniel Ferris, PhD

314-935-3187dan.ferris@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Dan Ferris, PhD

314-935-3187dan.ferris@wustl.edu

Principal Investigator:

Dan Ferris, PhD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

  • Food Is Medicine
  • Medically Tailored Meals
  • Food Security
  • Cancer Survivorship
  • Stepdown Intervention
  • Nutrition Education
  • Community-Engaged Research

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.